Effects of Sensorimotor Insoles on Stability and Gait in Patients With Multiple Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Stability
研究概览
简要总结
This single-blind, randomized controlled clinical trial aims to evaluate the long-term effects of using sensorimotor insoles (SMIs) on stability and gait capacity in individuals diagnosed with multiple sclerosis (MS). Secondary objectives include assessing the impact of SMIs on plantar cutaneous sensitivity, ankle muscle strength, quality of life, and overall functional status in this patient population.The study sample comprises 50 adult participants diagnosed with MS (including relapsing-remitting, primary progressive, and secondary progressive subtypes) with Expanded Disability Status Scale (EDSS) scores ranging from 2.0 to 6.0. Participants will be randomly allocated into an experimental group ($n = 25$) and a control group ($n = 25$). The experimental group will receive custom "Anatomy Line" SMIs (Springer Aktiv GmbH), fabricated using 3D digital foot models generated via the Foot Scan 3D mobile application. The intervention spans seven months, beginning with a one-month progressive adaptation period before transitioning to daily, full-day use within habitual footwear. The control group will receive no study-specific intervention, and participants in both groups will maintain their conventional physical therapy regimens throughout the study.All outcome measures will be evaluated at baseline and immediately following the 7-month intervention period by research team members who are blinded to group allocation. Primary outcomes include stability, evaluated using the Berg Balance Scale (BBS), and gait capacity, assessed via the Gait Assessment and Intervention Tool (GAIT). Secondary outcomes include plantar cutaneous sensitivity evaluated at three plantar sites using Semmes-Weinstein monofilaments, ankle muscle strength measured across four movement planes using an Activforce 2 digital handheld dynamometer, and health-related quality of life and functional status assessed through the 52-item Functional Assessment of Multiple Sclerosis (FAMS) questionnaire.
详细描述
This study is a single-blind, randomized controlled clinical trial designed to evaluate the long-term physiological and functional effects of sensorimotor insoles (SMIs) in individuals diagnosed with Multiple Sclerosis (MS).
Intervention Protocol and Device Customization Participants allocated to the experimental group receive custom-fabricated SMIs (Anatomy Line model, Springer Aktiv GmbH, Berlin, Germany). Digital foot models are generated using a mobile application (Foot Scan 3D) coupled with a specialized phone mirror device to capture three-dimensional foot morphology for custom orthosis manufacturing.
To ensure patient safety, promote acclimatization, and minimize potential adverse events, a structured 1-month adaptation protocol is implemented:
Adaptation Phase (Month 1): Participants wear the SMIs starting at 1 hour per day, increasing wear time by 1 hour every 3 days. SMI usage is initially restricted to indoor activities before expanding to outdoor use.
Maintenance Phase (Months 2-7): Following adaptation, participants wear the custom SMIs continuously during all daily activities within their habitual footwear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical diagnosis of multiple sclerosis (MS), including relapsing-remitting, primary progressive, or secondary progressive subtypes.
- •Age > 18 years.
- •Expanded Disability Status Scale (EDSS) score between 2.0 and 6.0 (ranging from minimal disability to requiring a cane to walk).
- •Signed written informed consent.
排除标准
- •Cognitive impairment.
- •Visual or vestibular disorders that could impair stability.
- •Changes in disease-specific medication within the 2 months prior to study baseline.
- •MS relapse within the 2 months prior to study baseline (for relapsing-remitting MS cases).
- •Lower-limb capsuloligamentous injury within the 2 months prior to study baseline (such as ankle or knee sprains) that could affect stability or gait pattern.
结局指标
主要结局
Stability
时间窗: 6 months
Berg Balance Scale
次要结局
- Gait(6 months)
- Plantar cutaneous sensitivity(6 months)
- Ankle strength(6 months)
- Function and Quality of life(6 months)
研究者
Daniel García García
Assistant professor of physical therapy
University of Salamanca